Oftentimes, the only way for potential research subjects to learn about a new clinical trial is through recruitment materials. These materials, such as flyers, advertisements, and letters, are an important part of a research study, and are considered to be the beginning of the informed consent process. While neither the Office of Human Research Protection (OHRP) nor the Food and Drug Administration (FDA) address subject recruitment in their regulations, both require that an IRB review methods and materials used to recruit study subjects. The question becomes, then, what materials must you submit to the IRB for review? Read this whitepaper to learn more.
New Blog: "Ask the IRB Experts"
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In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago. Since then, the IRB developed a well-organized process for its partnerships with independent IRBs.
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
